Clearmind Reaches Key Milestone: CMND-100 Phase IIa now Underway for Alcohol Use Disorder Trial, One-Third of Part C Enrolled

Clearmind Medicine (Nasdaq: CMND) reported that Part C Phase IIa of its double-blind, placebo-controlled Phase I/IIa trial of lead candidate CMND-100 for Alcohol Use Disorder (AUD) is now underway, with six patients enrolled to date across two Israeli centers.

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) reported that Part C Phase IIa of its double-blind, placebo-controlled Phase I/IIa trial of lead candidate CMND-100 for Alcohol Use Disorder (AUD) is now underway, with six patients enrolled to date across two Israeli centers.

Three participants were enrolled at Tel Aviv Sourasky Medical Center and three at Hadassah Medical Center in Jerusalem, marking the first multiple-dose treatment phase in AUD patients after successful completion of the initial safety part in healthy volunteers. The four-part study evaluates single and multiple dose safety, tolerability and pharmacokinetics of CMND-100 in healthy volunteers and individuals with moderate-to-severe AUD. An independent Data and Safety Monitoring Board previously reviewed Part A data and recommended advancing the study, supporting continued clinical evaluation and progression into multiple dosing in healthy volunteers and single dosing in AUD patients.

Positive

• Phase IIa AUD trial underway with six patients enrolled across two centers
• DSMB review of Part A supported advancing to subsequent trial parts
• First multiple-dose treatment phase in AUD patients initiated for CMND-100
• Four-part design covers single/multiple dose safety and pharmacokinetics in volunteers and AUD patients

Negative

• None.

Argus Sep 1 session 13 alerts

-5.67% close to close 81.9x rel. volume Open Argus

Details

Market move: CMND -5.67% in the Sep 1 session. Phase IIa trial initiation

+3.2% Peak Tracked

-14.7% Trough Tracked

$3.16M Mkt Cap at Peak Alert

On Sep 1, the day this news came out, CMND closed 5.67% below the previous close. Argus tracked a peak move of +3.2% during that session. Argus tracked a trough of -14.7% from its starting point during tracking. Our momentum scanner recorded 13 alerts for this stock that day. Relative volume reached 81.9x the daily average during tracking.

Data tracked by StockTitan Argus for the Sep 1 session.

Key Figures

Patients enrolled: 6 patients Enrollment progress: One-third TASMC enrollment: 3 participants +3 more

Patients enrolled

6 patients

Phase IIa CMND-100 AUD trial

Enrollment progress

One-third

Part C enrollment

TASMC enrollment

3 participants

Tel Aviv Sourasky Medical Center

Hadassah enrollment

3 participants

Hadassah Medical Center in Jerusalem

Study structure

Four-part

Phase I/IIa clinical study

Trial phase

Phase IIa

Multiple-dose treatment phase of Part C

Historical Context

5 past events · Latest: Aug 24

5 events

1. Aug 24

   IP collaboration milestone

   24h Move

   -3.5%

   Collaboration advanced with U.S. publication of a patent application covering MDMA-PEA combinations.

2. Aug 24

   IP portfolio milestone

   24h Move

   -3.5%

   Clearmind advanced its MDMA and N-acylethanolamines intellectual-property program.

3. Aug 13

   Clinical progression

   24h Move

   +12.1%

   DSMB approved advancement after the primary safety endpoint was achieved.

4. Aug 11

   Formulation study results

   24h Move

   -0.3%

   Intranasal MEAI demonstrated positive permeation results in comparative testing.

5. Aug 06

   DSMB progression milestone

   24h Move

   -0.6%

   DSMB cleared progression of the CMND-100 AUD study to Parts B and C.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

neuroplastogen, double-blind, placebo-controlled, pharmacokinetic, +1 more

5 terms

neuroplastogen medical

"advancing non-hallucinogenic psychedelic-derived neuroplastogen"

A neuroplastogen is a drug or compound designed to boost the brain’s ability to rewire and form new connections, enhancing recovery or adaptation after injury, stress, or disease. For investors, these molecules matter because they target underlying brain repair processes rather than just masking symptoms, offering the potential for durable benefits in conditions like depression, neurodegeneration, or cognitive decline—akin to giving a tired garden fresh tools to regrow and reshape itself.

double-blind medical

"the next stage of its double-blind, placebo-controlled Phase I/IIa clinical trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"double-blind, placebo-controlled Phase I/IIa clinical trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

pharmacokinetic medical

"single and multiple dose tolerability, safety and pharmacokinetic study"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

data and safety monitoring board regulatory

"an independent Data and Safety Monitoring Board (“DSMB”) reviewed the clinical data"

An independent panel of experts that watches over a clinical trial to protect participants and ensure the data are reliable, acting like an impartial referee who can recommend pausing or stopping the study if safety problems or clear benefits emerge. Investors care because the board’s findings can change a drug or device’s timeline, cost, and odds of regulatory approval, directly affecting a company’s value and risk profile.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Vancouver, Canada, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment  of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), announced today the initiation of Phase lla, the next stage of its double-blind, placebo-controlled Phase I/IIa clinical trial evaluating CMND-100 for the treatment of AUD, with six patients enrolled to date. Three participants have been enrolled at Tel Aviv Sourasky Medical Center (TASMC) and three at Hadassah Medical Center in Jerusalem, initiating the first multiple-dose treatment phase of Part C (“phase IIa”) following the successful completion of the trial’s initial safety part in healthy volunteers.

The ongoing Phase IIa clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of CMND-100 in individuals with moderate-to-severe AUD. The clinical trial is structured as a four‑part Phase I/IIa study single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and subjects with AUD. CMND-100 is Clearmind’s lead investigational psychedelic-based therapeutic candidate, currently in development as a potential treatment for AUD, a chronic condition characterized by an impaired ability to stop or control alcohol consumption despite significant social, occupational or health consequences. AUD remains a major global health burden, with substantial unmet medical needs and limited effective treatment options.

The Company previously reported that an independent Data and Safety Monitoring Board (“DSMB”) reviewed the clinical data generated during part A of the trial and recommended advancing to the subsequent parts of the study. This positive DSMB assessment supports the continued clinical evaluation of CMND-100 and the simultaneously progression of the program into multiple dosing in healthy volunteers and single dosing in AUD patient population.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage biopharmaceutical company advancing the discovery and development of non-hallucinogenic, next-generation, psychedelic-derived neuroplastogens for the scalable treatment of widespread and underserved health problems  of neuropsychiatric, metabolic, and addiction disorders, including alcohol use disorder. 

The Company’s intellectual portfolio currently consists of nineteen patent families, including 32 granted patents. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations

invest@clearmindmedicine.com

www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the ongoing conduct of its Phase I/IIa clinical trial evaluating CMND-100 for the treatment of alcohol use disorder (AUD), anticipated patient enrollment activities, the continued clinical development of CMND-100, the potential of CMND-100 as a treatment for AUD, and the Company's plans to provide additional updates regarding the study and related clinical activities. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Clearmind (Nasdaq: CMND) announce about its CMND-100 Phase IIa trial for Alcohol Use Disorder?

Clearmind announced that Part C Phase IIa of its CMND-100 trial for Alcohol Use Disorder is now underway with six enrolled patients. According to Clearmind, this marks the first multiple-dose treatment phase in AUD patients within its ongoing four-part Phase I/IIa study.

How many patients are enrolled in Clearmind’s CMND-100 Phase IIa AUD trial as of September 1, 2026?

As of September 1, 2026, Clearmind reported six patients enrolled in the CMND-100 Phase IIa AUD trial. According to Clearmind, three participants are at Tel Aviv Sourasky Medical Center and three at Hadassah Medical Center in Jerusalem.

What is the design of Clearmind’s Phase I/IIa clinical trial of CMND-100 for AUD (CMND)?

Clearmind’s CMND-100 trial is a four-part Phase I/IIa single and multiple dose study in healthy volunteers and AUD subjects. According to Clearmind, it assesses tolerability, safety and pharmacokinetics, and includes a double-blind, placebo-controlled structure with both single and multiple dosing phases.

What did the independent DSMB conclude about Clearmind’s CMND-100 trial for Alcohol Use Disorder?

The independent DSMB reviewed Part A data and recommended advancing to subsequent trial parts. According to Clearmind, this positive safety assessment supports continued clinical evaluation of CMND-100 and progression into multiple dosing in healthy volunteers and single dosing in AUD patients.

Where is Clearmind conducting the CMND-100 Phase IIa Alcohol Use Disorder trial?

Clearmind’s CMND-100 Phase IIa AUD trial is being conducted at Tel Aviv Sourasky Medical Center and Hadassah Medical Center in Jerusalem. According to Clearmind, each site has enrolled three patients so far in the multiple-dose treatment phase.

What condition is Clearmind’s CMND-100 targeting in the current Phase IIa trial for CMND shareholders?

The CMND-100 Phase IIa trial targets moderate-to-severe Alcohol Use Disorder in enrolled patients. According to Clearmind, CMND-100 is a non-hallucinogenic psychedelic-derived neuroplastogen being developed as a potential treatment for AUD, which has significant unmet medical need globally.